Trial · NCT02420717
Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia
NCT02420717, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2022-05-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia. Trials, record NCT02420717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02420717
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia
- NCT number
- NCT02420717
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Recurrent B Acute Lymphoblastic Leukemia, Recurrent Ph-Like Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, Refractory Ph-Like Acute Lymphoblastic Leukemia
- Interventions
- Cyclophosphamide, Cytarabine, Dasatinib, Dexamethasone, Doxorubicin, Laboratory Biomarker Analysis, Leucovorin, Mercaptopurine, Methotrexate, Prednisone, Rituximab, Ruxolitinib Phosphate, Vincristine
- First posted
- 2015-04-20
- Last updated
- 2025-06-08
- Results first posted
- 2022-05-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I) | 42 days | The method of Thall, Simon and Estey will be used for toxicity monitoring for this study. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 whenever possible. Safety data will be summarized by category, severity and frequency. |
| Primary | Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II) | 42 days | Complete Response (CR) is disappearance of all clinical and/or radiologic evidence of disease, Neutrophil count ≥ 1.0 x 10\^9/L, Platelet count ≥ 100 x 10\^9/L, Normal bone marrow differential (≤ 5% blasts), No extra-medullary leukemia. Complete Remission with Incomplete Blood Count Recovery (CRi) is CR except for ANC \< 1.0 x 10\^9/L and/or platelets \< 100 x 10\^9/L. |
| Secondary | Overall Survival | Up to 4 years 7 months | Time from date of treatment start until date of death due to any cause or last Follow-up. |
| Secondary | Progression-free Survival | Up to 4 years 7 months | Time from date of treatment start until the date of first objective documentation of disease-relapse. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I) | 42 days | Two out of nine participants were not Analyzed for response because they did not receive all planned study medication. | Milligrams (mg) | NUMBER |
| PRIMARY | Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II) | 42 days | Two out of five participants in the Ruxolitinib 15mg arm were not Analyzed for response because they did not receive all planned study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to 4 years 7 months | Two out of five participants in the Ruxolitinib 15mg arm were not Analyzed for response because they did not receive all planned study medication. | Months | MEDIAN |
| SECONDARY | Progression-free Survival | Up to 4 years 7 months | Two out of five participants in the Ruxolitinib 15mg arm were not Analyzed for response because they did not receive all planned study medication. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I) | Phase I Ruxolitinib 15mg | 25 | Milligrams (mg) | ||
| Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II) | Phase I Ruxolitinib 15mg | 0 | Participants | ||
| Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II) | Phase I Ruxolitinib 20mg | 1 | Participants | ||
| Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II) | Phase I Ruxolitinib 25mg | 0 | Participants | ||
| Overall Survival | Phase I Ruxolitinib 15mg | 4.8 | Full Range 2.4 to 11.3 | Months | |
| Overall Survival | Phase I Ruxolitinib 20mg | 5.4 | Full Range 1.4 to 16.3 | Months | |
| Overall Survival | Phase I Ruxolitinib 25mg | 38.5 | Full Range 4.9 to 41.9 | Months | |
| Progression-free Survival | Phase I Ruxolitinib 15mg | 2.3 | Full Range 1.5 to 11.3 | Months | |
| Progression-free Survival | Phase I Ruxolitinib 20mg | 1.8 | Full Range 1.3 to 5.4 | Months | |
| Progression-free Survival | Phase I Ruxolitinib 25mg | 1.9 | Full Range 1.8 to 3.1 | Months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I Ruxolitinib 15mg | 5 | |
| Overall Study | STARTED | Phase I Ruxolitinib 20mg | 3 | |
| Overall Study | STARTED | Phase I Ruxolitinib 25mg | 3 | |
| Overall Study | COMPLETED | Phase I Ruxolitinib 15mg | 3 | |
| Overall Study | COMPLETED | Phase I Ruxolitinib 20mg | 3 | |
| Overall Study | COMPLETED | Phase I Ruxolitinib 25mg | 3 | |
| Overall Study | NOT COMPLETED | Phase I Ruxolitinib 15mg | 2 | |
| Overall Study | NOT COMPLETED | Phase I Ruxolitinib 20mg | 0 | |
| Overall Study | NOT COMPLETED | Phase I Ruxolitinib 25mg | 0 |
Source ClinicalTrials.gov
Adverse events111
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine Aminotransferase Increased | Investigations | Phase I Ruxolitinib 15mg | 1 | 5 | 1 |
| other | Alanine Aminotransferase Increased | Investigations | Phase I Ruxolitinib 20mg | 0 | 3 | 0 |
| other | Alanine Aminotransferase Increased | Investigations | Phase I Ruxolitinib 25mg | 0 | 3 | 0 |
| other | Alkaline Phosphatase Increased | Investigations | Phase I Ruxolitinib 15mg | 1 | 5 | 1 |
| other | Alkaline Phosphatase Increased | Investigations | Phase I Ruxolitinib 20mg | 0 | 3 | 0 |
| other | Alkaline Phosphatase Increased | Investigations | Phase I Ruxolitinib 25mg | 0 | 3 | 0 |
| other | Aspartate Aminotransferase Increased | Investigations | Phase I Ruxolitinib 15mg | 1 | 5 | 1 |
| other | Aspartate Aminotransferase Increased | Investigations | Phase I Ruxolitinib 20mg | 0 | 3 | 0 |
| other | Aspartate Aminotransferase Increased | Investigations | Phase I Ruxolitinib 25mg | 0 | 3 | 0 |
| other | Back Pain | General disorders | Phase I Ruxolitinib 15mg | 0 | 5 | 0 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I Ruxolitinib 15mg | 2 | 5 |
| Total, all-cause mortality | Phase I Ruxolitinib 20mg | 1 | 3 |
| Total, all-cause mortality | Phase I Ruxolitinib 25mg | 1 | 3 |
| Total, other adverse events | Phase I Ruxolitinib 15mg | 5 | 5 |
| Total, other adverse events | Phase I Ruxolitinib 20mg | 3 | 3 |
| Total, other adverse events | Phase I Ruxolitinib 25mg | 1 | 3 |
| Total, serious adverse events | Phase I Ruxolitinib 15mg | 5 | 5 |
| Total, serious adverse events | Phase I Ruxolitinib 20mg | 3 | 3 |
| Total, serious adverse events | Phase I Ruxolitinib 25mg | 3 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02420717
GET https://conductscience.org/api/trials/v1/NCT02420717/events?page=2